Exercise as Intervention in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— ADRENALINE  

Official title:

Randomised Controlled Clinical Trial of Exercise as Intervention in Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396611
• Other study ID #: CLL_FADEUP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Universidade do Porto
• Contact: Pedro MP Cunha, MSc.
• Phone: +351912458876
• Email: pedrocunha[@]fade.up.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with Chronic Lymphocytic Leukemia (CLL).

DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a maximal cycle ergometer test, 2) Body Composition, 3) Muscle strength, 4) physical activity levels, 5) blood measures (e.g. immune and inflammatory functions).

DATA ANALYSES & SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.

HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers.

Description:

PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with CLL and without any prior treatment.

DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a Cardiopulmonary Exercise Test with Electrocardiogram (CPET+ECG) maximal cycle ergometer test, 2) a dual-energy X-ray absorptiometry (DEXA) Body Composition test, 3) a Muscle strength test with dynamometry, 4) a characterization of physical activity (PA) levels with accelerometry, and 5) blood measures (e.g. immune and inflammatory functions). The REx group will undertake a strength-based type of training with intensities near 80% of 1-Repetition Maximum (1-RM), with individual supervision (personal training approach).

DATA ANALYSES & SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.

HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers. It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of CLL as per the International Workshop on CLL Guidelines

• No history of previous treatment of CLL

• Able to walk on a treadmill or cycle ergometer

• Able to carry weights, or use weight machines

• Pass initial evaluations (CPET for cardiac health, Isokinetic for muscular health)

• Willing to adhere to the exercise program

• Signed informed consent

Exclusion Criteria:

• Previous CLL treatments

• Ongoing engagement in a regular exercise program

• Indication of disease progression and for starting treatment within 6 months

• Other primary tumour

• Inability to perform exercise (Heart disease, advanced stage respiratory, renal, hepatic, neurological, or osteoarticular disease)

• Unable to travel to FADEUP facilities or comply with other study requirements

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Behavioral:
• Exercise Training as Intervention
Supervised Exercise Training as an Intervention using Resistance Training.

Locations

Country	Name	City	State
Portugal	Faculty of Sport of University of Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Research Centre in Physical Activity, Health and Leisure

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VO2 peak as measured by cardiopulmonary exercise test	Cardio metabolic CPET + Stress ECG	Baseline to 16-weeks
Primary	Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test	BIODEX Concentric/Concentric Strength Test for Lower Body evaluation	Baseline to 16-weeks
Primary	Change in muscular strength (grip force in kg) as measured by dynamometer exercise test	JAMAR Hand Grip for Upper Body Evaluation	Baseline to 16-weeks
Primary	Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test	1 Repetition Maximum For Strength Evaluation of Whole Body	Baseline to 16-weeks
Primary	Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)	DEXA Test for Whole Body Composition	Baseline to 16-weeks
Primary	Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)	DEXA Test for Bone Mineral Density	Baseline to 16-weeks
Secondary	Change in Health Related Quality of Life as measured by FACIT-F questionnaire	Questionnaire The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), a 40-item measure that assesses self-reported fatigue.	Baseline to 16-weeks
Secondary	Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires	Questionnaire from EORTC Quality of Life Group (EORTC QLQ-C30) a 30-item instrument designed to measure quality of life in all cancer patients, with the supplement of CLL17 a 17-item instrument designed to measure quality of life in chronic lymphocytic leukemia patients	Baseline to 16-weeks
Secondary	Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days	GT9XLink accelerometer from Actigraph to collect data of the Physical Activity patterns, over a period of seven consecutive days, with a minimum of 10 hours of daily assessment	Baseline to 16-weeks
Secondary	Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection	Peripheral Blood Collection during Hospital Consultation	Baseline to 16-weeks
Secondary	Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection	Peripheral Blood Collection during Hospital Consultation	Baseline to 16-weeks
Secondary	Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection	Peripheral Blood Collection during Hospital Consultation	Baseline to 16-weeks